Agency Information Collection Activities: Proposed Collection: Public Comment Request, 59942-59943 [2013-23774]
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59942
Federal Register / Vol. 78, No. 189 / Monday, September 30, 2013 / Notices
Most important, the Activity
Scorecard provides incentive for
hospitals to conduct activities that will
increase the number of registered
donors throughout the nation. A list of
hospitals that reach these levels will be
shared with all campaign participants
during monthly webinars, in monthly
campaign e-newsletters from HRSA, and
in communications pieces sent out by
the campaign’s ten national partners,
which include the American Hospital
Association, the Association of Organ
Procurement Organizations, and the
American Society of Transplant
Surgeons. In addition, OPOs, DLA
affiliates, participating state hospital
associations, HRSA, and the national
partners can use the results to recognize
hospital participation and successes.
The ‘‘write-in’’ option that allows
hospitals to list additional activities will
help to identify best practices that can
be shared with all hospital partners on
monthly webinars.
Likely Respondents: A hospital
representative, most often the organ
donation champion identified by the
OPO, can download the form from
organdonor.gov or receive it from their
OPO or Donate Life America (DLA)
affiliate.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Form name
Number of
respondents
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
National Hospital Organ Donation Campaign’s Activity
Scorecard .........................................................................
1000
1
1000
0.36
360
Dated: September 20, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–23772 Filed 9–27–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received
within 60 days of this notice.
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SUMMARY:
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Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
The Stem Cell Therapeutic Outcomes
Database OMB No. 0915–0310—
Revision
Abstract: The Stem Cell Therapeutic
and Research Act of 2005, Public Law
(Pub. L.) 109–129, as amended by the
Stem Cell Therapeutic and Research
Reauthorization Act of 2010, Public Law
111–264 (the Act), provides for the
collection and maintenance of human
blood stem cells for the treatment of
patients and research. HRSA’s
Healthcare Systems Bureau has
established the Stem Cell Therapeutic
Outcomes Database. Operation of this
database necessitates certain record
keeping and reporting requirements in
order to perform the functions related to
hematopoietic stem cell transplantation
under contract to the U.S. Department of
ADDRESSES:
PO 00000
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Health and Human Services (HHS). The
Act requires the Secretary to contract for
the establishment and maintenance of
information related to patients who
have received stem cell therapeutic
products and to do so using a
standardized, electronic format. Data is
collected from transplant centers by the
Center for International Blood and
Marrow Transplant Research and is
used for ongoing analysis of transplant
outcomes. HRSA uses the information
in order to carry out its statutory
responsibilities. Information is needed
to monitor the clinical status of
transplantation and to provide the
Secretary of HHS with an annual report
of transplant center-specific survival
data. The increase in burden is due to
an increase in the annual number of
transplants and increasing survivorship
after transplantation.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
E:\FR\FM\30SEN1.SGM
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Federal Register / Vol. 78, No. 189 / Monday, September 30, 2013 / Notices
information. The total annual burden
hours estimated for this Information
59943
Collection Request are summarized in
the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Form Nnme
Number of
respondents
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Baseline Pre-TED (Transplant Essential Data) ...................
Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) ........................................................
100-Day Post-TED ...............................................................
6-Month Post-TED ...............................................................
12-Month Post-TED .............................................................
Annual Post-TED .................................................................
200
38
7,600
1
7,600
200
200
200
200
200
29
38
31
27
104
5,800
7,600
6,200
5,400
20,800
1
0.85
1
1
1
5,800
6,460
6,200
5,400
20,800
Total ..............................................................................
200
........................
53,400
........................
52,260
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Dated: September 20, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–23774 Filed 9–27–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Interactive
Informed Consent for Pediatric Clinical
Trials
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute Heart, Lung, and
Blood Institute (NHBLI), the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval. The 60-day FRN
was published 05/9/2013 (Vol. 78, No.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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90, page 27243). No public comments
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institute of Dental and Craniofacial
Research (NIDCR), National Institutes of
Health, may not conduct or sponsor,
and the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: NIH
Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Victoria Pemberton, Clinical
Trials Specialist, NHLBI, 6701
Rockledge Drive, Room 8102, MSC
7940, Bethesda, MD 20892 or call nontoll-free number (301) 435–0510 or
Email your request, including your
address to: pembertonv@nhlbi.nih.gov.
Formal requests for additional plans and
FOR FURTHER INFORMATION CONTACT:
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instruments must be requested in
writing.
Proposed Collection: Interactive
Informed Consent for Pediatric Clinical
Trials, 0925–New, National Heart, Lung,
and Blood Institute (NHLBI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: This study will compare
parents’ and children’s understanding of
information about a hypothetical
clinical trial presented using either a
standard paper consent document or an
interactive computer-based consent
program. Parents’ and children’s
understanding, regardless of whether
they received the standard consent or
the interactive computer-based program,
will be assessed by face-to-face
interview. In addition, parents’ and
children’s perceptions of, and
satisfaction with, the information
presented will be evaluated by
completion of a short questionnaire. The
primary hypothesis to be tested is that
interactive computer-based research
consent information is better
understood and accepted by parents and
children compared with the standard
paper consent document. Given that
many individuals have difficulty
reading and interpreting standard
written consent documents, this
technology holds promise as a means to
optimize the consent and assent process
particularly among individuals with low
literacy and numeracy skills.
OMB approval is requested for 18
months. There are no costs to
respondents other than their time. The
total estimated annualized burden hours
are 190.
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]]>Agencies
[Federal Register Volume 78, Number 189 (Monday, September 30, 2013)]
[Notices]
[Pages 59942-59943]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23774]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (HRSA) announces plans to submit an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks
comments from the public regarding the burden estimate, below, or any
other aspect of the ICR.
DATES: Comments on this Information Collection Request must be received
within 60 days of this notice.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 10-29, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email paperwork@hrsa.gov or call the HRSA
Information Collection Clearance Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: The Stem Cell Therapeutic
Outcomes Database OMB No. 0915-0310--Revision
Abstract: The Stem Cell Therapeutic and Research Act of 2005,
Public Law (Pub. L.) 109-129, as amended by the Stem Cell Therapeutic
and Research Reauthorization Act of 2010, Public Law 111-264 (the Act),
provides for the collection and maintenance of human blood stem cells
for the treatment of patients and research. HRSA's Healthcare Systems
Bureau has established the Stem Cell Therapeutic Outcomes Database.
Operation of this database necessitates certain record keeping and
reporting requirements in order to perform the functions related to
hematopoietic stem cell transplantation under contract to the U.S.
Department of Health and Human Services (HHS). The Act requires the
Secretary to contract for the establishment and maintenance of
information related to patients who have received stem cell therapeutic
products and to do so using a standardized, electronic format. Data is
collected from transplant centers by the Center for International Blood
and Marrow Transplant Research and is used for ongoing analysis of
transplant outcomes. HRSA uses the information in order to carry out
its statutory responsibilities. Information is needed to monitor the
clinical status of transplantation and to provide the Secretary of HHS
with an annual report of transplant center-specific survival data. The
increase in burden is due to an increase in the annual number of
transplants and increasing survivorship after transplantation.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the
[[Page 59943]]
information. The total annual burden hours estimated for this
Information Collection Request are summarized in the table below.
Total Estimated Annualized burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Form Nnme Number of responses per Total responses per response Total burden
respondents respondent (in hours) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Baseline Pre-TED (Transplant Essential Data)....................... 200 38 7,600 1 7,600
Product Form (includes Infusion, HLA, and Infectious Disease Marker 200 29 5,800 1 5,800
inserts)..........................................................
100-Day Post-TED................................................... 200 38 7,600 0.85 6,460
6-Month Post-TED................................................... 200 31 6,200 1 6,200
12-Month Post-TED.................................................. 200 27 5,400 1 5,400
Annual Post-TED.................................................... 200 104 20,800 1 20,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total.......................................................... 200 ............... 53,400 ............... 52,260
--------------------------------------------------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Dated: September 20, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-23774 Filed 9-27-13; 8:45 am]
BILLING CODE 4165-15-P
